BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS

    K Number: K984273 · Decision Jan 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    24
    Applicant Total
    44
    Review Days
    56

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    Basic Information

    Device Name
    FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS
    K Number
    K984273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ciba Vision Corporation
    Date Received
    November 30, 1998
    Decision Date
    January 25, 1999
    Product Code
    MVN
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MVN Lens, Contact, (Disposable)

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    Other Clearances by Ciba Vision Corporation

    K Number Device Name
    K133176 AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
    K123994 DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
    K113168 DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
    K083216 CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
    K073459 CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
    K072777 CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
    K062262 CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS
    K041820 SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
    K050250 AQUIFY MULTIPURPOSE SOLUTION
    K050065 FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
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